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The FIFARMA annual Regional Meeting was held in Miami between May 23rd and 24th 2017. FIFARMA member Companies and Local Associations gathered together to review the activities developed by FIFARMA in the last year, and also to discuss FIFARMA’s strategy for the following year.

The first day started with a brief joint presentation by PhRMA, BIO and FIFARMA in which the main priorities in LATAM and the areas of common work and collaboration were highlighted. Afterwards, Local Associations had the opportunity of discussing activities and priorities with the Co-Chairs of the FIFARMA Working Groups in order to ensure alignment and pertinence of the FIFARMA regional strategy at a local level.

In the afternoon a discussion on Healthcare Sustainability was developed, which was initiated by the presentation of the Puerto Rico experience with the SUSI (Sustainable Strategic Initiative) project made by Ivan Roman, PIA Director. Afterwards, the participants discussed strategies to develop a healthcare sustainable model locally in each Local Association.

At the end of the first day, the representatives of the majority of the companies and associations signed the commitment to adhere to the Pharma Integrity principles, a project developed by Transparency International and FIFARMA.

The participation of guest speakers allowed the consideration of topics that are of pertinence for the industry currently. Dr. Juan Francisco Millan from Cetifarma shared the experience with compliance in Mexico, Chrisoula Nikidis from APEC presented APEC activities on compliance and ethics, Ramiro Gilardino from ISPOR mentioned the activities that ISPOR is doing in Latam and finally Thomas O Keefe from Mercosur Consulting group, provided a brief update of the current initiatives of pooled procurement in the region.

In the second part of the afternoon, Rodney Lopez from MSD, did a presentation about counterfeiting in LATAM, a topic of high relevance to the industry and the healthcare authorities in the region. This was followed by a short presentation on the participation of FIFARMA in the Fight the Fakes Campaign from IFPMA, a campaign that aims at creating awareness about the impact and the damage of fake medicines in patients. Finally, Luis Villalba FIFARMA Director General did a brief update of the TI-FIFARMA code of conduct project and closed the meeting.

The meeting opened a space to discuss FIFARMA initiatives and main goals to implement the strategy for 2017-2018.

Up until 2016, cardio-metabolic diseases research in Latin America was, figuratively speaking, left in the dark. No one had yet conducted a study regarding these potentially life-threatening cardiovascular conditions such as heart failure, myocardial infarction, atrial fibrillation, and hypertension, which is why Novartis in partnership with Deloitte Access Economics took this opportunity to shine a light on the economic burden that patients of cardiovascular and metabolic diseases in the region are facing – and the results were shocking.

About 89.6 million people in Latin America – that’s 27.7% of the adult population in the region – are diagnosed with heart disease every year and the annual cost reaches up to USD $30.9 billion, which is equivalent to twice the cost of organizing the Rio 2016 Olympic Games. In Latin America, the prevalence of risk factors such as hypertension are very high, and there are fewer resources to fight other diseases. Thus, this exacerbates the burden on patients’ lives and national health care budget. Nine countries were selected for the study across Latin America that, together, comprised a representative sample of nations with different economic and population sizes, lower and higher relative income per capita, and different types of health systems: Mexico, Brazil, Chile, Colombia, Ecuador, Peru, Venezuela, Panama, and El Salvador.

The groundbreaking Novartis-Deloitte study was presented for the first time at the World Congress of Cardiology & Cardiovascular Health in 2016, followed by a roadshow around 6 countries in 2017 led by Lynne Pezzullo, the principal investigator of the study. These presentations had the intent of raising awareness around the core challenges, the economic impact on the countries, and identify opportunities to gain political will for tackling the problem among key stakeholders, media, and government health agencies.

Leading startups in Brazil presented their healthcare innovation projects as part of BioStartUp Lab, an entrepreneurship acceleration program organized by BiominasBrasil in partnership with INTERFARMA.

For two and a half months, 21 startups participated in lectures and training sessions to help develop and improve their healthcare innovation concepts. 15 of the participating startups were selected to participate in “demoday.” During “demoday,” finalists were given the opportunity to demonstrate the functionalities of their innovation to the attending audience.

“We have to change the name of this program to the ‘stubborn group’ because to bet on innovation in Brazil, you need persistence,” said INTERFARMA’s executive–president Antônio Britto when introducing the winning start-ups.

The winner of BioStartUp Lab was PackID. PackID provides real-time cold chain monitoring to help manufacturers and distributors manage the transportation of cold-sensitive products. CUCO Health took second place with an application that alerts patients when it is time to take their medicine and provides disease education while monitoring their treatment consumption.

FIFARMA Local Associations Meeting 2017 took place in Santiago de Chile, Chile between January 19th and 20th 2017 in the Renaissance Hotel.

Local Associations Directors of Latin America and FIFARMA gathered together to analyzed the current situation of the Healthcare system in Latin America and define the course of action and FIFARMA support to Local Associations. Local Associations Directors shared pressing initiatives they have been supporting in each country to boost the development of patient centric policies. FIFARMA will support projects to foster the improvement of patient´s health in Latin American countries which were discussed and analyzed during the meeting.

On the second day the participants had the opportunity to discuss and analyze “The path towards Universal Health Coverage (UHC)” with Manuel Espinoza, ISPOR Director and to discuss other key issues that are affecting the access of patients to innovative medicines in the region with Ayelet Haran from PhRMA and Justin Pine from BIO.

The meeting reinforced the compromise of FIFARMA members and Local Associations to support the development of Healthcare Sustainable systems in the region that foster the access to high quality pharmaceutical innovative products that improve life of patients in Latin America.

PANDRH Conference took place between October 19th and 21st in the Ministry of Foreign Affairs in Mexico City. The main theme of the Conference was “Regulatory Convergence for Health. Building capacity, expanding access and facilitating regulatory cooperation in the Region of the Americas”.

FIFARMA provided three speakers from the member’s companies for the Conference. Jaime Oliveira from BAYER presented the benefit of convergence with international standards. Khyati Roberts from ABBVIE presented investment in regulatory systems: PDUFA and GDUFA and finally Gilfredo Navarro from JANSSEN gave a presentation on quality management systems. The presentations were very well received by the audience

FIFARMA has developed two position papers: Health Technology Assessment (HTA): Good Practices & Principles and Utilization of Multiple-Criteria Decision Analysis (MCDA) to Support Healthcare Decision Making. The two papers aim at reinforcing the importance of using the appropriate tools in the decision-making process when choosing a health technology.

The objective of the HTA paper is to explain the HTA process and the principles that must be followed when considering HTA. FIFARMA recognizes that HTA has emerged globally as the preferred discipline through which governments and payers are being recommended in their decisions about whether or not to pay for a technology (access and coverage) and how much (reimbursement). This has occurred in response to rising concerns about the high and growing costs of healthcare, in particular pharmaceutical expenditures.

As a key stakeholder in any HTA-based pricing and reimbursement system, the Pharmaceutical Industry is responsible of finding an effective way in which to partner with governments to shape both the design and ongoing application of HTA processes in order to achieve the highest level of opening and transparency, consultation and participation, fairness and credibility, predictability and independence, oriented to value.

Moreover, MCDA is a decision-making tool with increasing use in the healthcare sector, within HTA (Health Technology Assessment). MCDA is a structured, transparent, participative, consistent and legitimate tool to support healthcare decision making as it provides a systematic framework for breaking down a complex decision into a transparent and rational process that incorporates the priorities and values of stakeholders.

Real-world examples of effective MCDA implementation in healthcare decision making in both the public and private sector validate that MCDA can be applied to facilitate holistic assessments. It is the view of FIFARMA that MCDA should strongly be considered as a tool to support HTA and broader healthcare decision making such as the contracts and tender processes in order to foster transparency, fairness, and collaboration amongst stakeholders.

The papers can be accessed in the new FIFARMA web page www.fifarma.org in publications.